CABA-HFPEF: CAtheter-Based Ablation of Atrial Fibrillation vs. Conventional Treatment in Patients With Heart Failure With Preserved Ejection Fraction
Study Details
Study Description
Brief Summary
The objective of CABA-HFPEF is to test whether catheter ablation (CA) for atrial fibrillation (AF) can prevent adverse cardiovascular outcomes in patients with heart failure with preserved (HFpEF) or mildly reduced ejection fraction (HFmrEF).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
HFpEF accounts for approximately half of HF diagnoses and HFmrEF adds another 20%. HFpEF patients are predisposed to AF with a prevalence of AF up to 65%. Conversely, the presence of AF increases the likelihood of subsequent HFpEF by up to 4-fold across diverse populations. The vulnerable hemodynamic state in HFpEF patients due to LV diastolic dysfunction can be significantly affected by AF with loss of atrial contraction and reduction in cardiac output. Thus, presence of AF in HFpEF patients leads to a significant increase in hospitalization, mortality and stroke.
Restoring and maintaining sinus rhythm in patients with HFpEF and AF could reduce cardiovascular (CV) outcomes. Catheter ablation (CA), particularly when performed as initial rhythm control, results in less recurrences of AF than anti arrhythmic drug therapy. In patients with HF with reduced ejection fraction (HFrEF) and AF, CA showed a significant reduction in all-cause mortality and worsening HF admissions compared to medical therapy.
No randomized clinical trial has tested or is currently testing the effects of CA on CV outcomes in patients with HFmrEF or HFpEF and AF. To address this, CABA-HFPEF tests whether CA can improve CV outcomes compared to usual care in these patients. The results of CABA-HFPEF will critically extend the current evidence on ablation-based rhythm control to this large population in dire need for treatments that improve clinical outcomes.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Catheter Ablation Symptomatic HFmrEF or HFpEF patients with AF that meet I/E criteria will be randomized 1:1 to receive either CA or usual medical care without the aim of CA. Patients assigned to rhythm control group will be treated with catheter ablation as first line therapy to restore and maintain sinus rhythm, additionally to the therapeutic recommendations of the current ESC guidelines for the management of atrial fibrillation (AF) and the current ESC Heart Failure (HF) guidelines. |
Device: CE-marked Catheter Ablation
Once patients have been randomized to catheter ablation (CA) group, the ablation procedure will be performed within 4-8 weeks. CA will initially aim at pulmonary vein isolation.
|
| No Intervention: Usual Medical Care Symptomatic HFmrEF or HFpEF patients with AF that meet I/E criteria will be randomized 1:1 to receive either CA or usual medical care without the aim of CA. Subjects randomized to usual care will be treated according to current ESC guidelines for the management of AF and current ESC HF guidelines. Usual care of AF in the context of CABA-HFPEF consists of an initial treatment limited to rate control in addition to adequate antithrombotic therapy, typically oral anticoagulation. |
Outcome Measures
Primary Outcome Measures
- The primary outcome is defined as survival time free of the composite of cardiovascular death and total (first and recurrent) unplanned cardiovascular hospitalization (Heart failure, acute coronary syndrome or stroke). [Estimated first patient in to last patient out 48 months.]
Secondary Outcome Measures
- Cardiovascular death [The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months]
- Total (first and recurrent) unplanned cardiovascular hospitalization (HF, acute coronary syndrome, or stroke) [The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months]
- All-cause mortality [The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months]
- Unplanned hospitalization for atrial arrhythmia [The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months]
- Total (first and recurrent) planned and unplanned cardiovascular hospitalizations [The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months]
- Number of nights spent in hospital [The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months]
- Number of days alive and out of hospital [The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months]
- AF burden (percentage of AF at 12 months FU) [The secondary endpoints will be documented for at least 12 months following randomization.]
- Percentage change in left ventricular ejection fraction at 12 months FU [The secondary endpoints will be documented for at least 12 months following randomization.]
- Change in NYHA class (I-IV) at 12 months FU [The secondary endpoints will be documented for at least 12 months following randomization.]
- Change in EHRA score (I-IV) at 12 months FU [The secondary endpoints will be documented for at least 12 months following randomization.]
- Change in quality of life at 12 months FU (measured by KCCQ score) [The secondary endpoints will be documented for at least 12 months following randomization.]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥ 18 years
-
Signed written informed consent
-
Clinical evidence of symptomatic heart failure (NYHA Class II-III)
-
Paroxysmal or persistent atrial fibrillation (less than 12 months and not longer than 24 months, documented at least on one 12-lead ECG)
-
Left ventricular ejection fraction (LVEF) 40-49% OR LVEF ≥ 50% with at least one of the following HFpEF echocardiography findings (any local measurement made during the screening epoch):
-
LA enlargement defined by at least 1 of the following: LA width (diameter) ≥3.8 cm or LA length ≥5.0 cm or LA area ≥20 cm2 or LA volume ≥55 ml or LA volume index ≥29 ml/m2
-
Left ventricular hypertrophy (septal thickness or posterior wall thickness ≥1.1cm or relative wall thickness >0.42)
- Patients with at least 1 of the following:
-
HF hospitalization (defined as HF listed as the major reason for hospitalization) within 6 months prior to screening visit and NT-proBNP >200 pg/ml for patients not in AF or >600 pg/ml for patients in AF on screening ECG
-
NT-proBNP >300 pg/ml for patients not in AF or >900 pg/ml for patients in AF on screening ECG
Exclusion Criteria:
-
Patients not suitable for rhythm control of AF
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Previous left atrial CA or surgical therapy of AF
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Acutely decompensated HF, NYHA IV (patients can be enrolled after stabilization)
-
Valvular heart disease needing interventional or surgical treatment within 3 months
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Heart surgery within 3 months
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Heart transplant or listed for heart transplant or cardiac assist device implantation
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Untreated hypothyroidism or hyperthyroidism (after successful treatment of thyroid dysfunction, patients may be enrolled)
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Any disease that limits life expectancy to less than 1 year
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Severe renal dysfunction (stage V, requiring dialysis)
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Active infection
-
Women currently pregnant or breastfeeding
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Subject with participation in another interventional clinical trial during this study or within 30 days before entry into this trial
-
Women of childbearing potential without highly effective contraception (PEARL-Index < 1%),
-
Inability to comply with the study procedures
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Charité University Medicine Berlin, Campus Virchow Klinikum | Berlin | Germany | 13353 |
Sponsors and Collaborators
- Charite University, Berlin, Germany
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Kompetenznetz Vorhofflimmern e.V. (AFNET)
- Boston Scientific Corporation
Investigators
- Principal Investigator: Burkert Pieske, Prof. Dr., Director Department of Cardiology, Charité University Medicine Berlin, CVK
- Study Director: Abdul Parwani, Dr., Head of Electrophysiology; Charité University Medicine Berlin, CVK
- Study Chair: Paulus Kirchhof, Prof. Dr., Director Department of Cardiology, Heart and Vascular Center University Hamburg Eppendorf
- Study Chair: Stefan Kääb, Prof. Dr., Department of Cardiology, Ludwig-Maximilians-University Hospital Munich
- Study Chair: Tim Friede, Prof. Dr., Departement of Medical Statistics, University Medical Center Göttingen
- Study Chair: Roland Tilz, Prof. Dr., Head of Electrophysiology Department, University Hospital Lübeck
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CABA-HFPEF-DZHK27